Artificial intelligence (AI) health tech company Vocalis Health has obtained CE mark (EU) approval for its VocalisCheck for medical use as a screening tool for Covid-19.

A software-only product, VocalisCheck can be accessed using smartphones or other devices. The voice recording of users will be transformed into a picture (spectrogram) with 512 features when they simply count from 50 to 70.

Based on the voice recordings of Covid-19-positive subjects in clinical trials, the picture is compared using AI machine learning / deep learning techniques to a composite picture to decide whether there is a high or low association between them.

The technology can be integrated into existing mobile or web applications or can be accessed through a web-based portal.

Vocalis Health noted that VocalisCheck is not a diagnostic tool but is made to be used as a screening tool for offering a reliable risk score to support people who may need additional diagnostic testing.

It can help health systems to allocate diagnostic resources in an efficient manner.

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The company has also reported results from a clinical study carried out in partnership with India’s Municipal Corporation of Greater Mumbai (MCGM) at its NESCO COVID-19 Centre to validate VocalisCheck.

The study had more than 2,000 subjects. Results from an unblinded validation set of 288 subjects showed an AUC of 0.88, which translated to 81.2% accuracy, 80.3% sensitivity, and 81.4% specificity.

Vocalis Health co-founder, chief operating, and medical officer Dr Shady Hassan said: “PCR testing is being used to screen for Covid-19, which is an extremely expensive, resource-intensive, and time-consuming approach.

“Instead of misusing PCR testing for screening, utilising a highly scalable screening tool like VocalisCheck can fill a significant gap in the current approach to Covid-19 screening, with the ability to effectively funnel those with high risk of infection to the appropriate diagnostic test.”

VocalisCheck is proven to be reliable in detecting Covid-19 risk in multiple studies, including in India.